All terms
Pharmaceuticals and Medical Devices Agency
Japan's regulatory authority for medical devices, drugs, and regenerative medicine.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
Definition
PMDA conducts scientific reviews of marketing authorization applications and post-marketing safety for drugs and medical devices in Japan, working under the Ministry of Health, Labour and Welfare (MHLW). MHLW grants final approval under the Pharmaceutical and Medical Device Act (PMD Act). Devices fall into Classes I to IV: lower-risk devices are often certified by registered certification bodies, while higher-risk devices are reviewed by PMDA. Foreign manufacturers must appoint a Marketing Authorization Holder in Japan and register their manufacturing sites. What the regulation says
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's primary regulatory body for medical devices and pharmaceuticals, operating under the Ministry of Health, Labour and Welfare (MHLW). The PMDA conducts pre-market reviews for marketing authorization and oversees post-market safety, aligning with the Pharmaceutical and Medical Device Act (PMD Act). PMDA also accepts Medical Device Single Audit Program (MDSAP) reports as a substitute for parts of its own Quality Management System (QMS) inspections for eligible manufacturers.What this means in practice
Japan classifies devices into Classes I–IV. Higher-risk devices require Shonin approval; many Class II devices use third-party Ninsho certification. PMDA accepts MDSAP audits in lieu of QMS inspections for many manufacturers.Examples
- A manufacturer of a Class III implantable device submits a Shonin application to PMDA, including comprehensive clinical data and manufacturing site information.
- A company developing a Class II diagnostic imaging system opts for Ninsho certification by a registered third-party body, streamlining its pre-market review process through a trusted entity.
- A MedTech company with an MDSAP certificate uses it to satisfy PMDA's QMS inspection requirements for their manufacturing facility, reducing the need for separate audits.
Common pitfalls
- •A common misconception is that PMDA only reviews Shonin (higher-risk) applications; however, PMDA also oversees Ninsho (third-party certified) devices through audits and vigilance.
- •Manufacturers might overlook that while MDSAP is accepted, specific Japanese QMS requirements, as outlined in the PMD Act, still apply and must be met.
- •Failing to understand the nuances between Shonin and Ninsho pathways can lead to delays in market access for MedTech products in Japan.
- •Assuming that PMDA's focus is solely on pre-market approval, neglecting the significant post-market surveillance and reporting obligations it enforces, is a critical error.
Frequently asked questions
PMDA's authority covers the scientific review of marketing authorization applications for medical devices, in-vitro diagnostics, and pharmaceuticals, as well as their post-market safety under the Pharmaceutical and Medical Device Act (PMD Act).
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMore in Regulatory
· Same categoryRegulatory
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Regulatory
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Cited by
Where this term appears across MedTech Terms.
Ecosystems (2)
Latest in MedTech
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 2Regulator guidance and consensus· 2Tier 4Trade press and expert commentary· 1
Link health: 3 verified· last checked 2026-06-20
PMDA·1IMDRF·1RAPS·1
- 1PMDA English siteTier 2 VerifiedPMDApmda.go.jp
- 2IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.